# Oxalis Labs – FDA 483, Apr 24, 2026

Source: https://www.keypedia.com/records/483/oxalis-labs/bac20393-3926-42f6-b9c0-3215ab7dd15b

> FDA 483 for Oxalis Labs on April 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Oxalis Labs
- Inspection Date: 2026-04-24
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Oxalis Labs, a drug manufacturer in Solan, India, was cited by the FDA for significant deficiencies during an inspection. The firm failed to establish adequate written procedures for production and process controls, including a lack of independent validation for critical test parameters. Additionally, the inspection revealed unrepresentative in-process sampling methods and inadequately qualified manufacturing equipment.

## Related Documents

- [483 - 2025-03-14](https://www.keypedia.com/records/483/oxalis-labs/732aac14-eb14-4d67-b391-0957b77ae24a) — date: March 14, 2025
- [483 - 2023-06-02](https://www.keypedia.com/records/483/oxalis-labs/552cbaa6-34c7-4028-8967-c1abd47b2a83) — date: June 2, 2023
- [483 - 2019-08-02](https://www.keypedia.com/records/483/oxalis-labs/8b9b4378-e8d2-4a71-aeca-bab25b566f94) — date: August 2, 2019

## Related Officers

- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [Investigator](https://www.keypedia.com/people/karishma-g-gopaul/ec5be791-b76c-4a31-bbed-9395e576d2c3)

Company: https://www.keypedia.com/companies/oxalis-labs/bc19741c-c2c0-43bc-80ad-91eda4acf921

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8
